Field of Disclosure
This application relates generally to managing regulated content (e.g., FDA regulated content) on non-regulated storage platforms. In particular, the application relates to sharing regulated content stored on non-regulated storage platforms.
Description of the Related Art
Today, regulated content such as FDA regulated documents and files, are heavily regulated, including specific regulations around how such documents can be stored and how they can be accessed by users within an organization. This regulated content is typically required to be stored on validated systems in order to meet all of these regulations. This limits the ability of organizations to store their regulated content, and often requires expensive subscriptions by these organizations to regulated storage services that have gone through the procedures to meet and maintain their ability to store regulated content. These regulated storage platforms are more limited in storage capacity and capability, and are commonly a high expense for organizations for regulated content. Typically, cloud content management services or public cloud storage platforms are not validated to meet various requirements such as data integrity, data control, change and release management, and user acceptance testing requirements imposed by FDA regulations. Accordingly, while these non-regulated storage platforms are easy to use, often free, and provide a large amount of storage capacity, these storage platforms cannot be used for managing regulated documents and files.
Another inconvenience for companies with regulated content is that these companies often have to use multiple storage platforms for managing regulated and non-regulated content to meet their business needs and to comply with regulations. This is because specialized regulated document management systems are not designed for managing non-regulated business content and are typically not economically viable for managing both types of content. Managing multiple storage platforms can increase operational costs and reduce operational efficiency. Using multiple storage platforms to manage regulated and non-regulated content can impede company-wide collaboration and may also prevent the companies from viewing content from a holistic perspective as distinct from a functional or process perspective.